Endometrial cancer: adjuvant chemoradiotherapy fails phase 3

  • Matei D & al.
  • N Engl J Med
  • 13 Jun 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • In patients with advanced endometrial carcinoma, adjuvant chemotherapy plus radiation (CRT) fails to improve recurrence-free survival (RFS) vs chemotherapy alone.

Why this matters

  • Chemotherapy alone remains the standard of care; findings suggest adding radiation may decrease tolerance and result in incomplete delivery of chemotherapy.

Study design

  • Phase 3 Gynecology Oncology Group (GOG)-258 trial of 736 patients with International Federation of Gynecology and Obstetrics stage III-IVA endometrial carcinoma, randomly assigned to adjuvant 6-month platinum-based CRT or chemotherapy.
  • Primary outcome: RFS (time to relapse/death).
  • Funding: National Cancer Institute.

Key results

  • Median follow-up duration, 47 months.
  • 75% of patients in the CRT vs 85% in chemotherapy group completed all planned chemotherapy cycles.
  • 60-month RFS was 59% with CRT group vs 58% with chemotherapy (HR, 0.90; P=.20).
  • At 60 months, CRT was associated with a lower 5-year incidence of:
    • vaginal recurrence (2% vs 7%; HR, 0.36; 95% CI, 0.16-0.82); and
    • pelvic and para-aortic lymph-node recurrence (11% vs 20%; HR, 0.43; 95% CI, 0.28-0.66).
  • Distant recurrence was more common with CRT (27% vs 21%; HR, 1.36; 95% CI, 1.00-1.86).
  • Fewer grade 3-5 adverse events were observed with chemoradiotherapy (58% vs 63%).
  • QoL: no clinically meaningful difference was observed at 70 weeks.

Limitations

  • OS data were not mature.

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